JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 103
- Locations
- 17
- Primary Endpoint
- Clinical Success
Study Overview
Brief Summary
This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).
Detailed Description
This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).
The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
- •Older than 18 years and skeletally mature;
- •Willing and able to comply with the study procedures;
- •Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
- •Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.
Exclusion Criteria
- •Meniscal tears in the avascular zone of meniscus;
- •Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;
- •Presence of active infection;
- •If female, subject is pregnant;
- •Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
- •The subject is unwilling or unable to give consent or to comply with the follow-up program;
- •Subject meets any contraindications of the appropriate Instruction for Use.
Arms & Interventions
Meniscal repair
Patients in need of meniscal repair
Intervention: JuggerStitch Meniscal Repair Device (Device)
Outcomes
Primary Outcomes
Clinical Success
Time Frame: From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at 1 year. Clinical success was defined as the absence of reoperation of the index knee due to a meniscal tear from the date of surgery through the participant's last available follow-up. All participants included in the analysis had at least 1 year of follow-up, and follow-up beyond 1 year was included when available.
Clinical Success
Time Frame: 1 year
The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
Secondary Outcomes
- International Knee Documentation Committee Subjective Knee Evaluation Form Score(Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively)
- Number of Adverse Events(From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years)
- Lysholm Knee Scoring Scale Score(Pre-operatively, 6 weeks, 6 months and 1 year post-surgery)
- Tegner Activity Scale Score(Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively)
- Number of Participants by Joint Line Tenderness Test Result(Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively)
- Number of Participants by McMurray Test Result(Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively)
- Monitoring of Adverse Events to confirm safety of the meniscal repair device(1 year)